Report: Options Exist to Improve EPA's Ability To Manage Its Chemical Review Program

EPA's reviews of new chemicals provide limited assurance that health and environmental risks are identified before the chemicals enter commerce, according to a report by the Government Accountability Office.

While the Toxic Substances Control Act (TSCA) authorizes EPA to promulgate rules requiring testing of chemicals if EPA has made certain findings, TSCA does not require chemical companies to test new chemicals for toxicity and to gauge exposure levels before they are submitted for EPA's review and, according to EPA officials, chemical companies typically do not voluntarily perform such testing, GAO officials stated. In the absence of such data, EPA predicts potential exposure levels and toxicity of new chemicals by using scientific models and by comparing them with chemicals with similar molecular structures (analogues) for which toxicity information is available.

However, the use of the models can present weaknesses in the assessment because the models are not always accurate in predicting physical chemical properties and the evaluation of general health effects is contingent on the availability of suitable analogues, GAO stated. "Nevertheless, given the lack of test data in general, and health and safety test data in particular available to the agency, EPA believes that the models are generally useful as screening tools for identifying potentially harmful chemicals and, in conjunction with other information chemical companies provide in premanufacture notices, such as the chemicals' estimated production volume and anticipated uses, provide for a reasonable review of new chemicals. By enabling EPA to screen chemicals for certain properties and characteristics, the models allow the agency to perform more detailed reviews of those chemicals that have properties and characteristics generally identified as posing potential risks to people and the environment.

EPA believes that, based on limited validation studies, its models are more likely to identify a false positive (where a chemical is determined to be of concern) than a false negative (where a chemical is initially identified as a low concern though on further analysis is actually of higher concern) GAO stated. EPA recognizes, however, that obtaining additional information from chemical companies could provide additional insight into chemical toxicities and improve the predictive capabilities of its models. Furthermore, the estimates of a chemicals' production volume and anticipated uses provided in the premanufacture notice, which EPA uses to assess exposure, can change substantially after EPA completes its review and manufacturing begins.

These estimates do not have to be amended by companies unless EPA promulgates a rule determining that a use of a chemical constitutes a significant new use, in which case a significant new use notice would be required. EPA does this for only a small percentage of new chemicals. However, the risk of exposure, and thus the risk of injury to human health or the environment, may increase when chemical companies increase production levels or expand the uses of a chemical, GAO stated.

Partly because of a lack of information on existing chemicals, EPA, in partnership with industry and environmental groups, initiated the High Production Volume Challenge Program in 1998, under which chemical companies began voluntarily providing information on the basic properties of chemicals produced in large amounts. It is unclear whether the program will produce sufficient information for EPA to determine chemicals' risks to human health and the environment, according to GAO.

EPA has limited ability to publicly share the information it receives from chemical companies under TSCA. TSCA prohibits the disclosure of confidential business information, and chemical companies claim much of the data submitted as confidential. While EPA has the authority to evaluate the appropriateness of these confidentiality claims, EPA states that it does not have the resources to challenge large numbers of claims. State environmental agencies and others are interested in obtaining confidential business information for use in various activities, such as developing contingency plans to alert emergency response personnel of the presence of highly toxic substances at manufacturing facilities. Chemical companies recently have expressed interest in working with EPA to identify ways to enable other organizations to use the information given the adoption of appropriate safeguards.

GAO recommends that the Congress consider providing EPA additional authorities under TSCA to improve its ability to assess chemical risks and that the EPA administrator take several actions to improve EPA's management of its chemical program. EPA did not disagree with GAO's recommendations but provided several comments, which are outlined in the report.

The report, Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program (GAO-05-458, June 13) can be accessed at

This article originally appeared in the 07/01/2005 issue of Environmental Protection.

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